Health TrialsbyHealthPanel

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

ConditionsLiquid BiopsyMelanoma (Skin)Melanoma Stage IIIMelanoma Stage IV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute

About this trial

The trial will test a paradigm-changing in vitro diagnostic device for Liquid Biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. A novel affinity-mediated transport amplification (AMT) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. The Versilib AMT photonic biosensor will test two analytes: the known actionable DNA mutation BRAF p.V600E, and a melanoma-restricted protein antigen. The results will be compared to digital PCR and ELISA methods.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age: ≥ 18

PFS≤2

Patients willing to sign an informed consent;

Confirmed (cytologically or histologically) cutaneous melanoma diagnosis

Disqualifiers

Life expectancy <8 weeks

Other clinical conditions preventing blood drawing compliance, as per physician's choice.

Trial population

BRAF V600E Melanoma patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling in addition to the blood normally required for their clinical management

    Procedure/Surgery

    Patients will undergo blood sampling in addition to the blood normally required for their clinical management. The study aims to collect 50 blood samples (one to 4) from 20 patients undergoing treatment in the adjuvant or advanced (metastatic) setting, as per standard of care. The first blood sample (T1) will be carried out immediately before the treatment, the subsequent blood samples (T2-T4) will coincide with the periodic radiographic re-evaluations, typically at months 3 and 6 (M3 and M6, T2 and T3), and at progression/recurrence, if and when recorded.

  • Blood plasma and circulating tumor DNA (ctDNA)

    Procedure/Surgery

    Blood drawing by venepuncture (elbow) in K2EDTA vacutainers to obtain blood plasma.The patients will otherwise receive the most appropriate treatment for their condition. The following data will be collected and pseudo-anonymised: demographic data (age and gender), histopathology including primary and metastatic sites, BRAF status, medical imaging, previous therapies assigned if any

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other.

Concordance will determine whether the Versilib approach is technically feasible, e.g. whether method is sound, tests meet minimal requirements (technical sensitivity, reproducibility, accuracy). False positives and false negatives will be assessed. The results of descriptive statistics will be the basis to elaborate specific hypotheses (e.g. clinical scenarios) that will be the subject of future studies.

Time frame
48 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regina Elena Cancer Institute

Lead sponsor

VTT Technical Research Centre, Finland

Collaborator

Institute of Health Information and Statistics of the Czech Republic

Collaborator

Universita degli Studi di Catania

Collaborator

FINNADVANCE (FIN)

Collaborator

PDC Biotech GmbH

Collaborator

Source ClinicalTrials.gov
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